Summary judgment is appropriate where the moving
party has shown that
“little or no evidence may be found in
support of the nonmoving
party's case. When no rational
jury could find in favor of the no nm oving
party because the
evidence to support its case is so slight, there is no
genuine
issue of material fact and a grant of summary
judgment is proper.”
Gallo v. Prudential Residential
Servs., L.P., 22 F.3d 1219, 1223-24 (2d
Cir. 1994)
(internal citations omitted).
B. 35 U.S.C. § 101 and Its
Scope
Section 101 of Title 35, United States
Code,
provides:
Whoever invents or discovers any new
and
Useful process, machine,
manufacture, or composition of matter,
or any new and
useful improvement
thereof, may obtain a patent therefore,
subject to the
conditions and
requirements of this title.
In interpreting
this language, the Supreme Court
has observed that “Congress plainly
contemplated that the
patent laws would be given wide scope.” Diamond
v.
96
Chakrabarty, 447 U.S. 303, 308 (1980); see
also J.E.M. Ag
Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S.
124,
131 (2001) (“[W]e are mindful that this Court has already
spoken
clearly concerning the broad scope and applicability
of §
101.”).
However, this broad reading of § 101 and
statutory
patent eligibility is not without limits. “The
Supreme Court has
recognized that scientific principles and
laws of nature, even when for the
first time discovered,
have existed throughout time, define the relationship
of
man to his environment, and, as a consequence, ought not to
be the subject of
exclusive rights to any one person.” In
re Meyer, 688 F.2d 789,
795 (C.C.P.A. 1982) (citing Leroy
v. Tatham, 55 U.S. 155, 175 (1852)).
Specifically, the
Supreme Court has recognized three categories of
subject-
matter that fall outside the scope of sect; 101: “The laws
of
nature, physical phenomena, and abstract ideas have been
held not
patentable.” Chakrabarty, 447 U.S. at 309;
see also Diamond v.
Diehr, 450 U.S. 175, 185 (1981).
“The rule
that the discovery of a law
of nature cannot be patented
rests, not on the notion that natural phenomena are
not
processes, but rather on the more fundamental understanding
that they are
not the kind of ‘discovery’ that
the
statute
97
was enacted to protect.” Parker v.
Flook, 431 U.S. 584,
593 (1918).
The exclusion of products
of
nature40 as
patentable subject matter
under § 101 also reflects the
Supreme Court's recognition that
‘[p]henomena of nature,
though just discovered, mental processes, and
abstract
intellectual concepts are not patentable, as they are the
basic tools
of scientific and technological work.”
Gottschalk v. Benson, 409
U.S. 63, 67 (1912). Thus, as
Justice Breyer has observed, “the reason
for this exclusion
is that sometimes too much patent protection can
impede
rather than ‘promote the Progress of Science and
useful
Arts,’ the constitutional objective of patent and
copyright
protection.” Lab. Corp. of Am. Holdings v. Metabolite
Labs.,
Inc., 548 U.S, 124, 126-21 (2006) (Breyer,
J.,
98
dissenting) (quoting U.S. Const., Art. I, § 8,
cl. 8.)
(emphasis in original). For these reasons, “manifestations
of
laws of nature [are] free to all men and reserved
exclusively to none.”
Funk Bros. Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 130
(1948).
The inquiry into an invention's patent
eligibility is a
fundamental one, and as such, “[t]he
ob1igation to determine what type of
discovery is sought to
be patented must precede the determination of whether
that
discovery is, in fact, new or obvious.” Flook,
437 U.S. at
593; see also In re Bilski, 545 F.3d 943, 950
(Fed. Cir. 2008) (en
banc), cert. granted, 129 S. Ct. 2735 (2009)
(”Whether a claim is
drawn to patent-eligible subject
matter under § 101 is a threshold inquiry,
and any claim of
an application failing the requirements of § 101 must
be
rejected even if it meets all of the other legal
requirements of
patentability.” (citing In re Comiskey, 499
F.3d 1365, 1372 (Fed.
Cir. 2007)); Prometheus Labs. v. Mayo
Collaborative Servs., 581 F.3d
1336, 1343 (Fed. Cir. 2009)
(noting that in determining patent eligibility,
“it is
improper to consider whether a claimed element or step in a
process
is novel or nonobvious, since such considerations
are separate requirements set
forth in 35 U.S.C. §§ 102 and
99
103,
respectively.” (citing Bilski, 545 F.3d at 958)).
Consistent with
this approach, the courts have rejected
patent claims even when the purported
invention was highly
beneficial or novel, or the research and work that
went
into identifying it was costly or time-consuming. See,
e.g., Funk
Bros., 333 U.S. at 130; Am. Fruit Growers, Inc.
v. Brodgex Co., 283
U.S. 1, 11-13 (1931); Gen. Elec. Co. v_
De Forest Radio Co., 28 F.2d
641, 642-43 (3d Cir. 1928).
The distinction between the § 101
inquiry into
patentable subject matter and the other requirements
for
patentability set forth in Title 35 is of particular
importance in
evaluating the authorities cited by the
parties and the arguments presented.
The discussion of §
101 in In re Bergy, 596 F.2d 952 (C.C.P.A.
1979) by the
late Honorable Giles S. Rich, one of the authors of the
1952 Patent
Act, is particularly informative in clarifying
the proper scope of a § 10l
analysis. There, Judge Rich
stated what considerations were salient—and
importantly,
what considerations were not—in a § 101
analysis:
Section 101 states three requirements:
novelty,
utility, and statutory subject matter. The
understanding that these
three requirements are
separate and distinct is long-standing and has
been
universally accepted.… Thus, the
questions of whether a particular
invention is
100
novel or useful are
questions wholly apart from
whether the invention falls into a category
of
statutory subject matter. Of the three
requirements stated in § 101,
only two, utility
and statutory subject matter, are applied under
§
101. As we shall show, in 1952 Congress voiced
its intent to
consider the novelty of an
invention under § 102 where it is first
made
clear what the statute means by “new,”
notwithstanding the fact
that this requirement is
first named in §
101.
Id. at 960-61 (emphasis added). Judge Rich
further
cautioned that “statements in the older cases must be
handled with
care lest the terms used in their reasoning
clash with the reformed terminology
of the present statute;
lack of meticulous care may lead to distorted
legal
conclusions.” Id. at 959. The Supreme Court
subsequently
affirmed this understanding of the § 101 analysis in
Diehr,
noting that while it had been argued that “novelty is
an
appropriate consideration under § 101,”
“[t]he question
…
of whether a particular invention is novel is ‘wholly
apart from
whether from whether the invention falls into a
category of statutory subject
matter.’” 450 U.S. at 189-90
(quoting Bergy, 596 F.2d at
961); see also _Bilski,
545 F.3d at 958 (“So here, it is
irrelevant to the
§ 101 analysis
whether Applicants' claimed process is
novel or non-
obvious.”).
101
dissenting) (quoting U.S.
Const., Art. I, § 8, cl. 8.)
(emphasis in original). For these reasons,
“manifestations
of laws of nature [are] free to all men and
reserved
exclusively to none.” Funk Bros. Seed Co. v. Kalo
Inoculant
Co., 333 U.S. 127, 130 (1948).
The inquiry into an invention's
patent
eligibility is a fundamental one, and as such, “[t]he
ob1igation to
determine what type of discovery is sought to
be patented must precede the
determination of whether that
discovery is, in fact, new or obvious.”
Flook,
437 U.S. at 593; see also In re Bilski, 545 F.3d 943,
950
(Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735
(2009)
(”Whether a claim is drawn to patent-eligible subject
matter under
§ 101 is a threshold inquiry, and any claim of
an application failing the
requirements of § 101 must be
rejected even if it meets all of the other
legal
requirements of patentability.” (citing In re Comiskey,
499
F.3d 1365, 1372 (Fed. Cir. 2007)); Prometheus Labs. v.
Mayo
Collaborative Servs., 581 F.3d 1336, 1343 (Fed. Cir. 2009)
(noting that
in determining patent eligibility, “it is
improper to consider whether a
claimed element or step in a
process is novel or nonobvious, since such
considerations
are separate requirements set forth in 35 U.S.C. §§ 102
and
102
As noted, the issue presented by the instant
motions
with regpect to the composition claims is whether
or not claims directed to
isolated DNA containing
naturally-occurring sequences fall within the products
of
nature exception to § 101. Based upon the reasons set
forth below, it
is concluded that the composition claims-
in-suit are excepted.
1.
Consideration of the merits of Plaintiffs'
challenge is
appropriate.
Myriad offers several arguments for why this
Court
should not engage the substance of Plaintiffs'
claims, but should instead
dismiss them out of hand.
Foremost among them is Myriad's assertion that
Plaintiffs'
claims should be dismissed in light of the
“carefully
considered policy of the USPTO,” which is “entitled
to
great respect from the courts.” Myriad Br. at 26. In so
arguing,
Myriad notes the presumption of validity afforded
to patents, see 35
U.S.C. § 282, and the USPTO's prior
consideration of the eligibility of
gene-related patents,
see Utility Examination Guidelines 66 Fed. Reg.
1092,
1092-99 (Jan. 5, 2001), as well as the Supreme Court's
statements in
J.E.M. Ag Supply, 534 U.S. 124.
103
The Federal Circuit
has previously held that it
owes no deference to USPTO legal determinations.
See,
e.g., Arnold P'Ship v. Dudas, 362 F.3d 1338, 1340 (Fed.
Cir. 2004)
(“This court reviews statutory interpretation,
the central issue in this
case, without deference.”).
While Congress has created a presumption of
validity for
issued patents, approximately 40% of patents challenged in
the
courts have been found invalid, demonstrating that this
presumption is far from
absolute. See Institute for
Intellectual Property & Information Law,
University of
Houston Law Center, Patstats.org, Full Calendar Year
2008
Report,
http://www.patstats.org/2008_Full_Year_Posting.rev3.htm
(indicating
that 40% of all validity determinations in
federal court in 2008 found the
challenged patent invalid);
Paul F. Morgan & Bruce Stoner, Reexamination v.
Litigation
— Making Intelligent Decisions in Challenging Patent
Validity,
86 J. Pat. & Trademark Off. Soc'y 441-461 (2004)
(citing USPTO statistics
showing that 74% of patents
previously issued by the Patent Office and later
challenged
through the reexamination process were either canceled or
changed by
the USPTO). Moreover, the lack of Congressional
action to specifically prohibit
gene patents in response to
the USPTO's prior grant of such patents does
not preclude
104
their review by the courts. For example, in
Bilski, 545
F.3d 943, the Federal Circuit set out a test for
the
patentability of method claims that potentially will
invalidate thousands of
patents on business method patents,
degpite Congress' silence concerning the
patentability of
such methods. Finally, while the Supreme Court in J.E.M.
Ag
Supply noted the USPTO's practice of issuing patents on
sexually reproducing
plants in concluding that such plants
represented patentable subject matter
under § 101, that
passing observation was neither dispositive nor central
to
the Court's holding and does not establish a rule of
judicial deference to
the USPTO's practices. See J.E.M. Ag
_Supply, 534 U.S. at 144-45.
Indeed, the judicial deference
urged by Myriad is difficult to reconcile with
the courts'
consideration of the substantive issues presented in cases
such
as Chakrabarty and indeed, J.E.M. Ag
Supply
itself.
Moreover, in the absence of a § 101 challenge
to
patent validity, the fact that courts have previously
upheld the validity of
patents directed to biological
products in response to § 102 and/or §
103 challenges has
no bearing on the present inquiry. See e.g., In
re Kubin,
561 F.3d 1351 (Fed. Cir. 2009) (considering obviousness
of
claims); In re O'Farrell, 853 F.2d 894 (Fed. Cir.
1988)
105
(same). The Patent Act sets out patent invalidity
as an
issue to be raised by the parties, see 35 U.S.C. § 282, and
it
would be erroneous to treat a case involving DNA-related
patents as holding that
isolated human genes constitute
patentable subject matter under § 101.
Were that the case,
the Supreme Court could have proceeded with
its
consideration of Metabolite Labs., after it granted
certiorari and
the parties and amici had fully briefed the
issue of patentable subject matter
eligibility, rather than
dismissing certiorari as improvidently granted based on
the
parties' failure to raise the § 101 issue below. 548
U.S.
124.
Finally, Myriad's suggestion that invalidating
the
patents-in-suit would constitute an unconstitutional
taking in violation of the
Fifth Amendment of the
Constitution or a violation of the United
States'
obligations under the Agreement on Trade-Related Aspects
of
Intellectual Property Rights (“TRIPS”) is unpersuasive.
Myriad's
novel takings argument runs counter to a long
history of invalidation of patent
claims by the courts and
is unsupported by legal precedent. Similarly, Articles
8.1
and 27.3 of TRIPS permit governments to incorporate public
health concerns
into their intellectual property laws and
106
to exclude from
patentability diagnostic, therapeutic, or
surgical methods as well as particular
inventions on the
grounds of public interest. As a result, invalidation of
the
patents-in-suit would constitute neither a
constitutional violation nor a
conflict with the United
States' treaty obligations.
2.
Patentable subject matter must be “markedly
different” from a
product of nature
Supreme Court precedent has established
that
products of nature do not constitute patentable subject
matter absent a
change that results in the creation of a
fundamentally new product. In
American Fruit Growers, the
Supreme Court rejected patent claims covering
fruit whose
skin had been treated with mold-resistant borax
acknowledging that
the “complete article is not found in
nature,” and “treatment,
labor and manipulation”
went into
producing the fruit, the Court
nonetheless held that the
fruit did not become an “article of
manufacture” unless it
“possesses a new or distinctive form,
quality, or property”
compared to the naturally-occurring
article.41
283 U.S. at 11. The Court went on to
observe:
107
Manufacture implies a change, but every
change is
not manufacture, and yet every change in an
article is the result of
treatment, labor, and
manipulation. But something more is
necessary.…
There must be transformation; a new and
different article
must emerge having a
distinctive name, character, or
use.
Id. at 12-13 (quoting Annheuser-Busch Brewing
Ass'n v.
United States, 207 U.S. 556, 562 (1908)) (internal citation
and
quotation marks omitted).
Similarly, in Funk Brothers, the
Supreme Court
considered whether a mixture of several
naturally-occurring
species of bacteria was
patentable.42
333 U.S. at 128-31.
Each species of
bacteria in the mixture could extract
nitrogen from the air for plant usage.
While the patent
holder had created a mixture by selecting and testing
for
strains of bacteria that did not mutually inhibit
one
108
another, the Court concluded that the patent holder
“did
not create a state of inhibition or of non-inhibition in
the
bacteria. Their qualities are the work of nature.
Those qualities are of course
not patentable.” Id. at 130.
Most recently, the Supreme
Court addressed the
application of § 101 to product claims in Diamond
v.
Chakrabarty, 447 U.S. 303. In Chakrabarty, the Court
considered
whether a “live, human-made micro-organism is
patentable subject matter
under 35 U.S.C. § 101.”
Id. at 305. The microorganism in
question was a bacterium that
had been genetically engineered to break down
multiple
components of crude oil and possessed considerable utility
in the
treatment of oil spills. Id. In concluding that
the man-made bacterial
strain was patentable, the Court
observed that the claim “is not to a
hitherto unknown
natural phenomenon, but to a nonnaturally occurring
manufacture
or composition of matter—a product of human
ingenuity ‘having a
distinctive name, character [and]
use.’” Id. at 309-10
(quoting
Hartranft v. Wiegmann, 121
U.S. 609, 615 (1887)). The Court
went on to contrast the
Chakrabarty bacterium with the bacterial mixture at
issue
in Funk Brothers, stating that in Chakrabarty's case,
“the
patentee has produced a new bacterium with
markedly
109
different characteristics from any found in
nature and one
having the potential for significant utility. His
discovery is
not nature's handiwork, but his own.…”
Id. at
310.43
This requirement that an invention
possess
“markedly different characteristics” for purposes of §
101
reflects the oft-repeated requirement that an invention
have “a new or
distinctive form, quality, or property” from
a product of nature. Am.
Fruit Growers, 283 U.S. at 11; In
re Merz, 97 F.2d 599, 601
(C.C.P.A. 1935) (“[M]ere
purification of known materials does not result
in a
patentable product,” unless “the product obtained in such
a
case had properties and characteristics which were
different in kind from
those of the known product rather
than in degree.”).
Courts have
also specifically held that
“purification” of a natural compound,
without more, is
insufficient to render a product of nature patentable.
In
The American Wood-Paper Co. v. The Fibre Disintearating
Co., 90 U.S.
(23 Wall.) 566 (1874), the Supreme Court held
110
that
refined cellulose, consisting of purified pulp derived
from wood and vegetable,
was unpatentable because it was
“an extract obtained by the decomposition
or disintegration
of material substance.” Id. at 593. As the
Court
observed:
There are many things well known and valuable
in
medicine or in the arts which may be extracted
from divers[e] substances.
But the extract is
the same, no matter from what it has been taken
A process to
obtain it from a subject from which
it has never been taken may be the creature
of
invention, but the thing itself when obtained
cannot be called a new
manufacture.
Id. at 593-94.44
Similarly, in Cochrane v. Badische
Anilin
& Soda Fabrik, 111 U.S. 293 (1884), the Court rejected a
patent
on an artificial version of a natural red dye called
alizarine that was produced
by manipulating another
compound through acid, heat, water or distillation.
See
generally, _id. Although the artificial version of the dye
was of a
brighter hue than the naturally occurring dye, the
Court concluded that
“[c]alling it artificial alizarine did
not make it a new composition of
matter, and patentable as
such.…” Id. at 311
(citing
Am. Wood-Paper, 90 U.S.
(23 Wall.) at
593).
111
In General Electric, 28 F.2d at 642, the
Third
Circuit Court of hppeals considered the patentability of
purified
tungsten, which possessed superior characteristics
and utility over its brittle,
naturally-occurring form.
The court first noted that “[i]f it is a natural
thing then
clearly, even if [the patentee] was the first to uncover it
and bring
it into view, he cannot have a patent for it
because a patent cannot be aHarded
for a discovery or for a
product of nature, or for a chemical element.”
Id. The
court went on to state:
Naturally He inquire
who created pure tungsten.
Coolidge? No. It existed in nature and
doubtless
has existed there for centuries. The
fact that no one before Coolidge found it
there
does not negative its origin or existence.
The second part of the
claim reads: “Having
ductility and high tensile strength.”
Did
Coolidge give those qualities to “substantially
pure tungsten”?
We think not for it is now
conceded that tungsten pure is ductile cold. If
it
possess that quality now it is certain that it
possessed it
always.
Id. at 643. The Court of Customs and Patent
Appeals
(“C.C.P.A.“), the precursor to the Federal Circuit Court
of
112
Appeals,45
subsequently relied on General
Electric in
rejecting patents claiming purified uraniwn and vanadium.
See
In re Marden, 47 F.2d 957, 957-58 (C.C.P.A. 1931)
(“Marden
I”); In re Marden, 47 F.2d 958,
1059 (C.C.P.A.
1931)
(“Marden II”) (“The quality of
purity of vanadium
or
its ductility is a quality of a natural product and as such
is not
patentable.”). Similarly, in Ex Parte Latimer, the
Patent
Commissioner refused to allow a patent on pine
needle fibers that were better
suited for textile
production, even though it was necessary to remove the
needle
from its sheath and other resinous material. 1889
Dec. Comm'r Pat. 123, 125
(1889) (“Nature made them so and
not the process by which they are taken
from the leaf or
needle.”).
Myriad argues that purification of
“‘naturally
occurring’ compounds that ‘do not exist in
nature in pure
form’ renders such compounds patent-eligible.”
Myriad Br.
at 21 (quoting In re Bergstrom, 427 F.2d 1394,
1401
(C.C.P.A. 1970)). However, Myriad cites no Supreme
Court
113
authority that would rebut the authorities presented
by
Plaintiffs, nor do the cited cases support
Myriad's
position.
Myriad has relied heavily on the holding of
the
Honorable Learned Hand in Parke-Davis & Co. v. H.K. Mulford
Co.
189 F.2d 95
(S.D.N.Y. 1911).46
In
Parke-Davis, Judge
Land considered a challenge to the validity of a
patent
114
claiming an adrenaline compound that had been
isolated and
purified from animal suprarenal glands. Id. at 97. It
had
been known that suprarenal glands in powdered form had
hemostatic,
blood-pressure-raising and astringent
properties, but could not be used for
those purposes in
gross form. The isolated adrenaline, however, possessed
the
desired therapeutic properties and could be
administered to
humans.
Although Myriad argues that the holding in
Parke-Davis
establishes that the purification of a natural
product necessarily renders it
patentable, the opinion,
read closely, fails to support such a conclusion.
The
question before the court in Parke-Davis was one of novelty
(a
modern-day § 102 question), not of patentable subject
matter (the §
101 question before this Court). In framing
the issue, Judge Hand observed
that, “[the validity of the
claims] is attacked, first, because they are
anticipated in
the art; and second, for a number of technical
grounds
which I shall take up in turn.” Id. at 101
(emphasis
added). He went on to conclude that the patented purified
extract was
not, in fact, different from the prior art
“only for a degree of
purity,” but rather was a different
chemical substance from that found in
the prior art. Id.
115
at 103 (observing that
“no one had ever isolated a
substance [adrenaline] which was not in salt
form” and that
“the [claimed] base [form of adrenaline] was an
original
production of [the patentee's]”). Thus, Judge Hand held
that the
purified adrenaline was not anticipated by the
prior art, namely, the ground
paradrenal gland that was
known to possess certain beneficial properties.
See Merck
& Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 162
(4th
Cir. 1958) (“It was further held [in Parke-Davis] that
the
invention was not anticipated, though the principle was
known to exist in
the suprarenal glands.”).
Only after concluding that the claimed
purified
adrenaline was novel over the prior art did Judge Hand
Offer, as dicta,
the statement to Which Myriad cites: “But,
even if it were merely an
extracted product without change,
there is no rule that such products are not
patentable.”
Id. at 103. While the accuracy of this statement at
the
time was written is dubious in light of American Wood-Paper
(to which
Judge Hand did not cite) it is certainly no
longer good law in light of
subsequent Supreme Court cases,
which, as noted above, require that a claimed
invention
possess “markedly different characteristics” over
products
existing in nature in order for it to constitute
patentable
116
subject matter.47
Chakrabarty, 447 U.S. at 310;
see also
Funk Bros., 333 U.S. at 130-32. By the same token, Judge
Hand's
suggestion that a claimed invention was patentable
since it was a “new
thing commercially and
therapeutically,” Parke-Davis, 189 F.2d at
103, is firmly
contradicted by subsequent case law establishing that
“it
is improper to consider whether a claimed element or step
in a process
is novel or nonobvious, since such
congiderations are separate
requirements” when evaluating
whether a claim is patent-eligible subject
matter.
Prometheus, 581 F.3d at 1343; see also Bergy, 596 F.2d
at
960-61. Such an approach would also be inconsistent with
the Supreme Court's
rejection of the patentability of the
commercially useful mixture of bacteria in
Funk Brothers,
the refined cellulose in American Wood-Paper, and
the
electromagnetic communication devices in O'Reilly v. Morse,
56 U.S.
(15 How.) 62 (1853).
The distinction between considerations of
novelty
and patentable subject matter similarly undermines Myriad's
reliance on
Bergstrom and In re Kratz, 592 F.2d 1169
(C.C.P.A. 1979), both of
which presented issues of novelty
117
and anticipation rather
than the question of patentable
subject matter. In Bergstrom, the
C.C.P.A. considered an
appeal from a rejection by the Board of Patent
and
Interferences (“BPAI”) of a patent claiming the
purified
rostaglandins PGE2 and PGE3 that had
been
extracted from
human or animal prostate glands. 427 F.2d at 1398.
Although
the BPAI cited § 101 in its rejection, the
C.C.P.A. recognized the issue as
a § 102 question of
novelty. Id. at 1400 (“Tested by the
conventional
evidentiary criteria or ‘conditions for
patentability’
relevant to the present factual situation which
Congress
has expressed in the various provisions of 35 U.S.C. §
102,
appellants are undoubtedly correct, for the Patent Office
has not been able
to … establish that the claimed
subject matter lacks
'novelty.’”);
see also id. at 1401
(“[T]he fundamental
error in the board's position, as we
see it, is the analysis and answer it gave
to the sole
issue it accurately posed - whether the claimed pure
materials are
novel as compared with the less pure
materials of the reference.”
(internal citation and
uotation marks omitted)). Indeed, the C.C.P.A. itself
has
subsequently recognized that Bergstrom is properly viewed
as a case
concerning novelty. Bergy, 596 F.2d at 961
(“Our research has
disclosed only two instances in which
118
rejections for lack
of novelty were made by the PTO under §
101.… In In re
Bergstrom we in effect treated the
rejection as if it had been made under
§ 102, obServing in
the process that ‘The word “new” in
§ 101
is defined and to
be construed in accordance with the provisions
of
§ 102.’”
(internal citation
omitted)).
Kratz examined the rejection of a patent claiming
a
substantially purified chemical compound naturally
occurring in strawberries,
called 2-methyl-2-pentenoic acid
(“2M2PA”). 592 F.2d at 1170. The
patentee had appealed
from the BPAI's determination that the purified
compound
was obvious over the prior art under § 103. See
_id.
Although there was some discussion about whether the
composition
claimed was a naturally-occurring compound, the
C.C.P.A. did not view the
question before it as a § 101
inquiry. Instead, the court treated the
appeal as a
question of novelty and anticipation pursuant to §
102.48
See, e.g., id. at 1174
(“It should be clear that an
119
anticipation rejection
in such a case is necessarily based
on a dual
footing.”).49
Finally, Merck & Co.,
Inc. v. Olin Mathieson
Chem. Corp., 253 F.2d 156, cited by Myriad, is
entirely
consistent with the principle set forth in Funk Brothers
and
American Fruit Growers that something derived from a
product of nature
must “possess a new or distinctive form,
quality, or property” in
order to become patentable subject
matter. Am. Fruit Growers, 283 U.S.
at 11.
In Merck, the
Fourth Circuit considered the validity of a patent
claiming
a Vitamin B12 composition useful for treating
pernicious
anemia. Id. at 157. Although naturally occurring
Vitamin
B12 produced in cows had known therapeutic properties and
was
commercially available, the court found the purified B12
Compositipn,
which was obtained from a microorganism,
patentable. In upholding the validity
of the patent, the
court held:
Every slight step in
purification does not
produce a new product. What is gained may be
the
120
old product, but with a greater
degree of purity.
Alpha alumina purified is still alpha alumina, In
re
Ridgway, 76 F.2d 602,[] and ultramarine from
which floatable impurities have
been removed is
still ultramarine, In re Merz, 97 F.2d 599
…
Id. at 163. Because the court concluded that
the purified
B12 was more than a “mere advance in the degree
of
purity of
a known product,” it determined that the claimed invention
was
entitled to patent protection. Id. at 164.
In sum, the clear
line of Supreme Court precedent
and accompanying lower court authorities,
stretching from
American Wood-Paper through to Chakrabarty,
establishes
that purification of a product of nature, without more,
cannot
transform it into patentable subject matter.
Rather, the purified product must
pogsess “markedly
different characteristics” in order to satisfy
the
requirements of § 101.
3. The claimed isolated DNA is not
“markedly different”
from native DNA
The question thus
presented by Plaintiffs'
challenge to the composition claims is whether the
isolated
DNA claimed by Myriad possesses “markedly
different
121
NOTES
40
Myriad distinguishes between “laws
of nature,”
”natural phenomena,”
and “abstract
ideas,” which it concedes are not patentable, and
“products of
nature,” for which it appears to argue no
prohibition to
patentability
exists. Although the digtinction between these two
categories is unclear, it
is well established that
“products of nature”
are not patentable.
See e.g., Chakrabarty, 447 U.S. at 13 (stating
that relevant distinction
for § 101 patentability is
“between products
of nature, whether
living or not, and human-made inventions”);
Gen. Elec. Co. v. De Forest
Radio Co., 28 F.2d 641, 642 (3d Cir. 1928)
(noting that “a patent
cannot be awarded for a discovery or for a
product of nature, or for a chemical
element”);
In re Marden, 47 F.2d 957, 957 (C.C.P.A. 1931)
(concluding that
“[u]ranium is a product of
nature, and the appellant is
not entitled to a patent on the same, or
upon any of the inherent natural
qualities of that metal”); In re
Marden, 47 F.2d 958, 959 (C.C.P.A.
1931) (stating that
“pure vanadium
is not new in the inventive sense,
and, it being a product of nature,
no one is entitled to a monopoly of the
same.”).
41
Myriad argues
that American Fruit Growers was decided on novelty
grounds, rather than
subject matter patentability. See Myriad Br. at
26. However, the Court's
novelty discussion was restricted to its
analysis of the process claims. Am.
Fruit Growers, 283 U.S. at 13-14
(“If it be assumed that the process
claims under consideration cover an
invention, we think this lacked novelty when
application was made for
the patent August 13, 1923”). In contrast, its
rejection of the
composition claims was based on an analysis of subject
matter
patentability. See id. at 11 (“Is an orange,
the rind of
which has
become impregnated with borax, through immersion in a solution,
and
thereby resistant to blue mold decay, a ‘manufacture,’
or
manufactured
article, within the meaning of section 31, title 35, U.S.
Code?”).
42
Myriad suggests
that the Supreme Court's holding in
Funk Brothers was
premised on an
obviousness determination, rather than patentable
subject matter. Subsequent
Supreme Court opinions, however, have
treated the holding in Funk
Brothers as a statement of patentable
subject matter. See
Chakrabarty, 447 U.S. at 309-lO;
F1ook, 437 U.S.
at 591-92;
Benson, 409 U.S. at 67-68.
43
Although Chakrabarty is often cited
for the proposition that
“anything under the sun that is made by
man” is patentable,
id. at 309,
that phrase is a misleading
quotation from the legislative history of
the Patent Act of 1952. The full
quote clearly acknowledges the
statutory limitations to patentable subject
matter: “A person may have
‘invented’ a machine or a
manufacture, which may include
anything under
the sun made by man, but it ig not
necessarily patentable under section
101 unless the conditions of the title are
fulfilled.” H.R. Rep. No.
1923, 82d Cong., 2d Sess. 6 (1952).
44
Given the posture of the challenge to the
patent's validity, the
Court rested its holding on the fact that the patent in
question was
invalid as non-novel. Id.
45
The decisions of the C.C.P.A. remain
binding precedent in patent
cases. See South CorD. v. Untted States, 690
F.2d J368, 1370-71 (Fed.
Cir. 19B2) (en banc) (adopting “[t]hat body of
law represented by the
holdings of … the Court of Customs and Patent
Appeals&rellip; as
“precedent” for the then-new Federal Circuit so
as to
“continu[el the
stability in those areas of the law previously
within the jurisdiction
of our predecessor courts”).
46
The invocation of Judge Hand is frequently
practiced in this Circuit.
See, e.g.,United States v. Rigas, 583 F.3d
108, 121 n.3 (2d Cir. 2009)
(quoting Learned Hand for the proposition that
appellate courts may not
find facts); United States v. Parker, 554 F.3d
230 (2d Cir. 2009)
(quoting Learned Hand for his formulation of the requirements
of
conspiracy); In re City of New York, 522 F.3d 279, 284
(2d Cir.
2008)
(citing Learned Hand for hi9 formulation of negligence);
In re
Hyman,
501 F.3d 61, 67 (2d Cir. 2007) (quoting at length Learned
Hand's
inconclusive discussion of the meaning of the
word
“defalcation” in 11
U.S.C. § 523(a)(4)); United States
v. Brand,
467 F.3d 179, 190 (2d Cir.
2006) (quoting Learned Hand's
definition of inducement by the
government); In re Enron Corp., 419 F.3d
115, 123 (2d Cir. 2005)
(quoting Learned Hand's critique of statutes of
limitations); Shannon
v._Jacobowitz, 394 F.3d 90, 95 (2d Cir. 2005)
(quoting Learned Hand's
instruction that “[w]ords are not pebbles in
alien
juxtaposition.&ellip;”);
Danahy v. Buscag1ia, 134 F.3d 1185,
1189 (2d Cir. 1998) (quoting
Learned Hand on the rationale for qualified
immunity). See a1so,
Remarks of the Honorable John N. Walker, Jr. Upon
Receiving the Learned
Hand Meda1 for Exce11ence in Federal Jurisprudence, 76
St. John's L.
Rev. 595, 596 (2002) (“Judge Hand is widely considered to
have been one
of the four greatest judges of the first half of the
twentieth
century.”); James L. Oakes, Personal Ref1ections on Learned
Hand and
the Second Circuit, 47 Stan. L. Rev. 387 (1995); Gerald
Gunther,
Learned Hand: the Man and the Judge (1994); Kathryn
Griffin,
Judge Learned Hand and the Ro1e of the Federa1 Judiciary
(1973);
Marvin Schick, Learned Hand's Court (1970);
Marcia Nelson, ed.,
The Remarkable
Hands: An Affectionate Portrait (1983); Hershel Shanks,
ed.,
The Art
and Craft of Judging: The Decisions of Judge Learned Hand
(1968).
Although Judge Hand once turned his back on the author of this
opinion
arguing before him on behalf of the Government, his opinion in
Parke-
Davis deserves careful review but brings to mind that oft
repeated
adage “Quote Learned, but follow Gus.” See
Oakes,
47 Stan. L. Rev. at
389 n.175. This author, confronted by genomics and
molecular biology,
also emphatically empathizes with Judge Hand's complaint
in
Parke-Davis
about his lack of knowledge of the rudiments of
chemistry.
See Parke-Davis, 189 F. at 114.
47
Notwithstanding Judge Hand's reputation,
see supra note 46, his
opinion in Parke-Davis was one of a
district court judge and does not
supersede contrary statements of the law by
the C.C.P.A. or the Supreme
Court.
48
The differences between the test applied
in Kratz and the “markedly
different” requirement set forth in
Chakrabarty
and other Supreme Court precedent further demonstrates
that
the Kratz court was engaged in a §
102 anticipation analysis and not
a § 101 statutory subject matter
analysis. See id. at 1174
(requiring, for a finding of anticipation,
that “the natural composition
must inherently contain the naturally
occurring compound” and that
“the claim must be of
sufficient breadth
to encompass both the known
natural composition and the naturally
occurring compound.”).
49
Bergy, also cited by Myriad,
considered the question of whether
microorganisms constituted patentable subject
matter, an issue
subsequently addressed by the Supreme Court in
Chakrabarty.
It did not
address the patentability of purified natural
products, and its
citation to Merck and Parke-Davis was only for
the purpose
of noting
that courts had upheld patents on pharmaceutical compounds
such as
vitamin B12 and adrenaline.
See Bergy, 596 F.2d at
974-75 & n.13.
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